BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1903406 · Received November 12, 2010

    Report

    Report Number
    2183996-2010-02300
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED ELEVATED BLOOD GLUCOSE OF 26.8 MMOL/L AND SAID THE INFUSION DEVICE DID NOT GIVE AN ERROR MESSAGE. PT REPORTED THE INFUSION DEVICE KEY-LOCK WAS ACTIVATED AUTOMATICALLY. PT BELIEVED THE INSULIN DELIVERY OF THE INFUSION DEVICE WAS INACCURATE. HYPERGLYCEMIA WAS CORRECTED BY DELIVERING INSULIN THROUGH INFUSION DEVICE. INFUSION SET IS CHANGED EVERY 2 DAYS. TARGET BLOOD GLUCOSE IS 5-8 MMOL/L. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED FOR EVAL. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET